Regulatory RoundUP

Ricardo CarvajalDirector
Hyman, Phelps & McNamara, P.C.

Ricardo Carvajal works with manufacturers and marketers of food and dietary supplements, OTC drugs, and cosmetics on a range of FDA, USDA, and FTC regulatory issues. Mr. Carvajal advises clients ranging from start-ups to multinational companies at all points in the supply chain, including bulk ingredient manufacturers, distributors of packaged goods, and retailers. He counsels clients on the regulatory status of ingredients and finished products, and provides advice on compliance with labeling and advertising requirements. He helps clients interpret and comment on the implementation of new requirements, such as those arising from the Food Safety Modernization Act. He also has expertise in FDA’s regulation of bioengineered plants and animals.

In enforcement matters, Mr. Carvajal counsels clients on managing inspections, responding to warning letters and other enforcement actions by federal and state regulators, and resolving import detentions. He also helps clients navigate product recalls and related corrective actions. Mr. Carvajal applies his subject matter expertise to corporate transactions, issuing opinions and conducting due diligence for acquisitions and IPOs.

Mr. Carvajal’s approach to counseling clients draws on insights gained in his former role as an Associate Chief Counsel at FDA, where he counseled the agency on a variety of rulemaking and enforcement activities and policy initiatives. Mr. Carvajal has served on the Food and Dietary Supplements Committee and the Global Committee of the Food and Drug Law Institute, and as Chair of the Public Policy Outreach and Implementation Task Force of the Institute of Food Technologists. He is also a member of the American Bar Association.

Stephen Ostroff, M.D., is the Deputy Commissioner for Foods and Veterinary Medicine at the U.S. Food and Drug Administration, a position he assumed in May 2016. In that role, he oversees the food and animal health activities of FDA, including FDA's responsibilities in the areas of food safety and nutrition, food labeling, food and color additives, cosmetics, dietary supplements, animal drugs and animal feed, and research to support the food and veterinary medicine mission of FDA.

Dr. Ostroff has also served as the acting FDA Commissioner on two occasions, from April 2015 to late February 2016 and again from January to May 2017.

Dr. Ostroff served as the FDA's Chief Scientist starting in February 2014. The Office of the Chief Scientist works closely with FDA's product centers, providing strategic leadership and support for FDA's regulatory science and innovation initiatives.

Dr. Ostroff joined FDA in 2013 as Chief Medical Officer in the Center for Food Safety and Applied Nutrition and Senior Public Health Advisor to FDA's Office of Foods and Veterinary Medicine.

Prior to that, he served as Deputy Director of the National Center for Infectious Diseases at the Centers for Disease Control and Prevention (CDC). At CDC Dr. Ostroff focused on emerging infectious diseases, food safety, and coordination of complex outbreak response. He retired from the Commissioned Corps of the U.S. Public Health Service at the rank of Rear Admiral (Assistant Surgeon General). Dr. Ostroff was also the Director of the Bureau of Epidemiology and Acting Physician General for the Commonwealth of Pennsylvania and has consulted internationally on public health projects in South Asia and Latin America.

Dr. Ostroff graduated from the University of Pennsylvania School of Medicine in 1981 and completed residencies in internal medicine at the University of Colorado Health Sciences Center and preventive medicine at CDC.

Robert C. Post, Ph.D., M.Ed., M.Sc., is the Senior Director, Chobani Health and Wellness/Corporate Affairs, at CHOBANI, LLC, the leading yogurt manufacturer. He drives nutrition, health, and wellness strategies around the brand’s current and future offerings, and navigates critical H&W issues toward the goal of improving community health through access to better food for more people. He also leads initiatives in government affairs related to agriculture, food, and nutrition policies. To help Chobani reach its goal of universal wellness, he designs and uses research in nutritional/physical, social (including workplace), and environmental wellbeing to support innovation, and partners with health organizations to improve trends in diet and health-related community health.

Dr. Post previously served as key nutrition advisor to the former White House/First Lady’s Office and collaborator on the White House Let’s Move! initiative. He was the senior executive leading USDA’s Center for Nutrition Policy and Promotion where he established national dietary guidance, the Dietary Guidelines for Americans, created USDA’s Nutrition Evidence Library, as well as directed Federal nutrition promotion, creating the MyPlate (ChooseMyPlate.gov) initiative. Previously, he was an administrator at Federal food and nutrition regulatory agencies, led Federal labeling policy and food standards programs, and was an R&D scientist in the food sector.

He currently serves as an appointed advisor to the Foundation for Food and Agriculture Research; as a member of the National Academies of Medicine Food Forum Advisory Board; on American Society for Nutrition research advisory groups; on the Society for Nutrition Education and Behavior Board of Trustees; and on the Board of Directors for the International Food Information Council, among other boards. From 2004 until 2012, Dr. Post was an adjunct professor in the Nutrition and Food Science Department at the University of Maryland.